Data Collection Technologies

EDC System Design / Implementation

The REGISTRAT-MAPI Data Management group will design and implement REGISTRAT-MAPI EDC based on study-specific EDC requirements developed in cooperation with the sponsor and REGISTRAT-MAPI professionals. Detailed information on EDC design is covered in the Data Management section.

Electronic Patient Reported Outcomes (ePRO) Solutions

Depending on study requirements, REGISTRAT-MAPI can use multiple technologies to collect PRO data. REGISTRAT-MAPI’s Web-based ePRO system allows users to enter data in an interview based format. Behind the interview is a complex data collection system that integrates an easy-to-use form with simple to complex error checking, tree guided interview paths, automatic notifications, and rapid setup features.

Interactive Voice Response System (IVRS)

REGISTRAT-MAPI’s IVRS integrates state-of-the-art information systems and computer and telecommunications technologies to provide a scalable solution that can be combined with other REGISTRAT-MAPI technologies. Our combination of technical expertise, clinical research experience, and IVRS experience allows us to provide centralized randomization, collection of patient reported outcomes, and drug management services for Late Phase studies and registries, as well as other applications that may be needed in the course of a study.

Patient Reported Outcomes (PRO)
The IVRS allows patients to enter study-related diary information or complete PRO instruments using a touch-tone telephone. Given the prevalence of telephones this is a preferred data collection method for patient reported outcomes. Typically, study sites enter or initialize enrolled patients into the IVRS, following which, patients can begin to enter diary information or complete PRO instruments.

Event Reporting
To streamline the reporting of specific events throughout the course of a study, such as serious adverse events, IVR can be used as a trigger to initiate manual processes or use of other technologies. The IVRS can receive information that can be triaged at REGISTRAT-MAPI, automatically sent via fax, or entered for review. Using multiple integrated technologies, processes can be streamlined and events tracked with a high degree of timeliness and accuracy.

REGISTRAT-MAPI Electronic Data Capture

REGISTRAT-MAPI uses a comprehensive, flexible, and 21 CFR part 11 compliant system designed to create efficiencies in the work flow process for clinical studies, enhance data accuracy, and in doing so, accelerate clinical study timelines. The Data Management module includes an eCRF creation tool, Designer Work Bench (DWB), the industry’s simplest drag and drop graphical tool. DWB enables data management professionals to easily design case report forms, create data validation rules for automatic edit checks, define code or decode lists, and automatically configure underlying database schema corresponding to each form. This process that typically takes six to twelve weeks can be done more expeditiously using DWB, depending on form elements, data cleaning strategies, and field types identified in the eCRF development process.

Key features of the REGISTRAT-MAPI EDC system include:

  • Customizable user interface allows for sponsor or study-specific branding
  • Flexible eCRF design capabilities make data entry more intuitive
  • eCRF screens are set up for ease of entry, incorporating drop down boxes, check boxes, radio selection boxes and dynamic fields to reduce data entry errors that can generate queries
  • Conditional form flow can be set up on a field or page level to allow for tree based entry of data
  • Pre-populated fields can be set up to eliminate redundant data entry
  • eCRF Completion Instructions are created as an online help tool
  • Online edit checks provide immediate feedback to the user if data is missing, out of range, or inconsistent with other data entered. Query management workflow can be designed to meet the specific needs of each study
  • User comments can be sent to a monitor for review in the field, so they can resolve queries and issue manual queries
  • CRF printing instantly generates printed images based on user need
  • Sponsor-defined study status reports are designed to provide real-time study metrics, such as patient enrollment counts and query management statistics
  • Data can be accessed real time through the use of custom reporting and dynamic charting modules that may include aggregate and blinded site and patient data. Data can be presented in Excel, PDF, or html format
  • Data transfers can be regularly scheduled via SAS transport files, SQL, text files, or specialized formats, as required, and as pre-determined according to sponsor specifications
  • Secure audit trail stores the previous value of altered data, user name, date, and time of change
  • Compliant with all requirements of key industry regulatory guidelines and computerized clinical data management conventions, including 21 CFR Part 11, ICH-GCP, and HIPAA

REGISTRAT-MAPI EDC is based on thin client architecture, and thus, requires no installation or downloading for study sites, participants, or the Sponsor. The core EDC solution, accessed via a secure Web page, includes customizable Web-based data entry screens, query management, built-in reporting capabilities, and a host of communication and reminder features. It is designed to provide quick study startup and powerful, flexible, on-going study administration.

The application is accessible via any system capable of supporting a mainstream browser with a connection speed of at least 56 kbps. REGISTRAT-MAPI EDC is a hosted application that features state-of-the-art physical and technological security to provide a tested, secure, and reproducible environment for data collection and storage.

Fax Scanning

REGISTRAT-MAPI's fax scanning system consistently delivers quality data using an established methodology. Sites will appreciate the ability to fax Enrollment Forms directly into REGISTRAT-MAPI and experience fast turnaround as they are imported into the REGISTRAK® Site Management System. Enrolled sites can fax Case Report Forms (CRFs) to REGISTRAT-MAPI for integration into REGISTRAT-MAPI's Clinical Data Management System (CDMS).

REGISTRAT-MAPI's highly skilled Data Management group can create customized forms for high-speed scanning or fax receipt based on study requirements. Scannable forms use anchor points to define fields, field types, and form flow. Forms can be disseminated to sites by mail or via a secure Internet portal.

Once forms are deployed, REGISTRAT-MAPI maintains both fax server capabilities and high-speed scanners to receive images. These images are exported to both the Optical/Intelligent Character Recognition (OCR/ICR) system and to REGISTRAT-MAPI's imaging system.

The OCR/ICR system software interprets the images and automatically performs OCR/ICR extraction, highlighting questionable entries to be reviewed by an operator. All fields are 100% verified to ensure completeness and accuracy of the database. Because the OCR application processes the majority of the information, entry operators spend seconds verifying questionable data rather than minutes manually keying entire forms.

Technology plays a significant part in a successful fax scanning system. REGISTRAT-MAPI's dedicated fax servers are available 24/7 for sites to fax CRFs or other data to REGISTRAT-MAPI. Our OCR/ICR system resides on redundant servers to ensure that information is processed quickly and efficiently. REGISTRAT-MAPI's OCR/ICR system is hosted in REGISTRAT-MAPI's secure hosting facility.